Cleared Traditional

ALGOPLAQUE HYDROCOLLOID DRESSING (K970518) - FDA 510(k) Clearance

K970518 · Laboratoires Urgo S.A. · General & Plastic Surgery device
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Mar 1997
Decision
38d
Days
-
Risk

K970518 is an FDA 510(k) clearance for the ALGOPLAQUE HYDROCOLLOID DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Laboratoires Urgo S.A. (St Louis, US). The FDA issued a Cleared decision on March 21, 1997 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laboratoires Urgo S.A. devices

Submission Details

510(k) Number K970518 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 11, 1997
Decision Date March 21, 1997
Days to Decision 38 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -